评估以泮托拉唑为基础的三联和四联疗法根除幽门螺杆菌的疗效

The evaluation of the efficacy of pantoprazole-based triple and quadruple therapy in Itelicobacter pylori eradication

目的比较以泮托拉唑为基础的7d标准三联疗法与泮托拉唑＋铋剂＋甲硝唑＋四环素的10d四联疗法根除Hp的疗效和安全性。方法170例非溃疡性消化不良的Hp感染者随机人选三联、四联治疗组。三联治疗组实行PAC方案：泮托拉唑40mg（2次／d）＋阿莫西林1．0g（2次／d）＋克拉霉素500mg（2次／d），口服7d。四联治疗组实行PBMT方案：泮托拉唑40mg（2次／d）＋胶体次枸橼酸铋220mg（2次／a）＋四环素750mg（2次／d）＋甲硝唑400mg（2次／d），口服10d。治疗结束后至少停药4周后复查^13C-尿素呼气试验，结果≤4‰为Hp阴性，表示根除成功。同时评估疗效及安全性。结果166例患者按方案完成治疗。三联治疗组按意图治疗分析（ITT）根除率为63．53％（54／85），较四联治疗组低E89．41％（76／85），x^2=17．168，P—0．000]。三联治疗组按实验方案分析（PP）根除率为65．06％（54／83），亦较四联治疗组低[91．57％（76／83），x^2=13．588，P—0．0001。从年龄段分析，年龄〉30岁者三联治疗组根除失败率为22．22％（4／18），较四联治疗组高[3．84％（1／26），（x^2=19．884，P—0．000]。三联和四联治疗组不良反应发生率分别为60．00％（51／85）和42．35％（36／85）。结论在7d标准三联疗法Hp根除疗效降低的情况下，含泮托拉唑、铋剂、四环素和甲硝唑的10d四联方案可考虑为首选方案。

Objective Compare the efficacy and safety of pantoprazole based 7-day standard triple therapy with 10-day quadruple therapy including pantoprazole, bismuth, metronidazole and tetracycline in Helicobacter pylori （H. pylori） eradication. Methods A total of 170 H. pylori positive patients with non-ulcer dyspepsia were recruited and randomly assigned into triple and quadruple therapy groups. The triple therapy group was implemented with PAC program which included orally taking pantoprazole 40 mg twice per day, amoxicillin 1.0 g twice per day and clarithromycin 500 mg twice per day for seven days. The quadruple therapy group was implemented with PBMT program which consisted of orally taking pantoprazole 40 mg twice per day, colloidal bismuth subcitrate 220 mg twice per day, metronidazole 400 mg three times per day and tetracycline 750 mg twice per day for ten days. The ^13C -urea breathe test was re-examined at least 4 weeks after the completion of treatment, the result lower than 4‰ was H. pylori negative which indicated the success of H. pylori eradication. The efficacy and safety were also evaluated. Results A total of 166 patients completed the treatment. With intention-to-treat （ITT） analysis, the H. pylori eradication rate in the triple therapy group was 63.5% （54/85）, lower than that of the quadruple therapy group （89.41%（76/85）,x^2=17.168,P=0.000）. With per protocol （PP） analysis, the eradication rate in the triple therapy group was 65. 060/00 （54/83）, also lower than that of the quadruple therapy group （91.57%（76/83）,x^2=13.588,P=0.000）. Through the age analysis, in patients over 30 years old, the eradication failed rate in the triple therapy group was 22. 22% （4/18）, higher than that of the quadruple therapy group （3. 84% （1 / 26）, x^2 =19. 884, P=0. 000）. The incidence of adverse reaction rates of the triple and quadruple therapy group were 60.00% （51/85） and 42.35% （36/85） respectively. Conclusion Sinee the reduction of eradication rate with seven day standard triple therapy, the 10-day pantoprazole, bismuth, metronidazole and tetracycline quadruple therapy may be considered as the first choice.